Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study
- Conditions
- Malignancy or Benign of Enlarged Lymph Nodes
- Registration Number
- NCT02939066
- Lead Sponsor
- Shandong University
- Brief Summary
Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes
Exclusion Criteria
- Patients aged <18 years or >80 years
- Known allergy to fluorescein dye
- Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
- Pregnancy or breastfeeding
- Inability to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The nCLE interpretation criteria for the characterization of malignant lymph nodes 20 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
🇨🇳Jinan, Shandong, China